Manager's Guide to Design and Conduct of Clinical Trials 

June 21st to July 24th 2009

Are you planning for a new clinical trial or are appraising a just-completed one?  A Manager's Guide to Design and Conduct of Clinical Trials covers:

·         Designing trials and determining sample size

·         Computer-assisted data collection and submission

·         Exception handling

·         Monitoring

·         Budgeting men and materials

·         Documentation and reports

·         After action review

Who Should Take This Course: Existing and would-be managers and entrepreneurs of pharmaceutical, medical device, and biologics firms

Instructor: Dr. Phillip Good, the seasoned instructor of this four-week internet course, has over twenty years experience in the pharmaceutical and device industry.  He is the author of The Manager's Guide to Design and Conduct of Clinical Trials (Wiley, 2002, 2006).  (The text is available separately to course participants at a 20% discount.)   He has given tutorials at the Joint Statistical Meetings (U.S.) and Deming Conference, lectured in Australia, Belgium, France, Holland, Ireland, and Spain, and was twice a traveling lecturer for the American Statistical Association. This is his sixth (6^th) year of providing on-line interactive courses.

Prerequisite: You should have familiarity with basic statistical concepts.  If not, we highly recommend Introduction to Statistics via Resampling Methods and R/S-Plus (Wiley, 2005).   Prior use of R, S-Plus or Stata is helpful.  Regretfully, few of these routines are available in SAS at this time.

Organization of the Course: The course takes place over the Internet.  During each course week, you participate at times of your own choosing - there are no set times when you must be online.  Course participants are given access to a private bulletin board that serves as a forum for discussion of ideas, problem solving, and interaction with the instructor. All students use aliases and their email addresses and company affiliations are concealed so that the open interchange of ideas is facilitated. 

The course is scheduled to take place over four weeks, and should require about 10 hours per week. At the beginning of each week, participants receive the relevant material, in addition to answers to exercises from the previous session. During the week, participants are expected to go over the course materials and work through exercises. Discussion among participants is encouraged. The instructor will provide answers and comments.

Course Requirements: The optional text is Manager's Guide to Design and Conduct of Clinical Trials Wiley, 2nd ed, 2005) by Dr. Good. The previous link allows you to order the text directly from Wiley. Wiley typically offers a 15% discount to statcourse.com customers during checkout time. PLEASE ORDER YOUR COPY BEFORE THE COURSE STARTING DATE. 

Course Program - The course is structured as follows:

Week 1:  Eight Guidelines

      Start with your reports

      Computer-assisted data entry

      Plug the holes as they arise

      Monitor person-power

      Pay only for results

      Lay the groundwork

      Plan, do, then check

Week 2:  Trial Design

      Should the study be performed?

      Study objectives

      End points

      Quality control

      Study population

      Timing

      Closure

Week 3:  Monitoring The Trials

      Walk through

      Site visits

      Maintaining investigator interest

      Patient retention

      Termination and extension

      Maintaining the budget

      Interim analyses

Week 4.  Analyzing the Results

      Documentation

      Report coverage

      Understanding data

      Exceptions and adverse events

      Equivalence

      Bad statistics

      After action review

Cost: $495 per participant.  ($375 for each additional person at the same firm, institution or government office.)  If you register before June 11th, you need pay only $450.  Students, faculty and research workers at academic institutions are eligible for a further discount. Just send an email from your academic or institutional email account to courses@statisticsonline.info to receive a discount coupon worth $75 toward the cost of the course.

Immediately after your payment is credited, you will receive an email giving you sign up instructions, and the web address (URL) of the course material.  Note that you will not be able to access this address until the start date of the course.